Pancreatic CancerBAMCTNCT03774589
Bilioenteric Anastomosis by Magnetic Compressive Technique
A study testing Magnetic Compressive Anastomosis and Manual Anastomosis in people with Pancreatic Cancer and Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma, Bile Duct Injury
- What is being tested?
- Magnetic Compressive Anastomosis and Manual Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age between 18 to 75
- Patients' gender was not limited
- Patients who were well-diagnosed and had the indication for bilioenteric anastomosis.
- Patients whose lifetimes will be longer than 12 months.
- Patients who are willing to join this clinical trial and informed consent form voluntarily.
Who cannot join
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of hepatic duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
- Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including:
- Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.
- Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yi Lv, MD，PHD, 0086-13991200581, luyi169@126.com
Rongfeng Wang, MD, 0086-15877553630, 15877553630@163.com
About this study
Official title: Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
Read the detailed description
The bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Bile Duct Injury, Choledochal Cyst, Biliary Calculi
- Being tested
- Magnetic Compressive Anastomosis, Manual Anastomosis
- Keywords
- bilioenteric anastomosis, magnetic compressive technique, morbidity
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Choledochal Cyst, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Compressive AnastomosisProcedure or surgery
The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.
Manual AnastomosisProcedure or surgery
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Compressive Anastomosis | Experimental | A magnetic device will be used during bilioenteric anastomosis. Receives: Procedure: Magnetic Compressive Anastomosis |
| Traditional Manual Anastomosis | Active comparator | A handsewn technique will be used during bilioenteric anastomosis. Receives: Procedure: Manual Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilioenteric anastomotic leakage
To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis
Measured: 1 month post operation
Secondary outcomes (4)
Length of bilioenteric anastomosis time
To compare the anastomotic time between magnetic and hand-sewn groups
Measured: during operation
Time from the date of operation to expel of the magnets.
To confirm the safe discharge of the magnets
Measured: 1 to 4 weeks postoperation
average length of postoperative hospital stay
To compare the length of stay between magnetic and hand-sewn groups
Measured: 3 months
Bilioenteric anastomotic stricture
To compare the long-term outcome between magnetic and hand-sewn groups
Measured: 1,3,6,12-month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Feb 2019
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University, Northwest Institute for Non-ferrous Metal Research
- Responsible party
- Sponsor
- Investigators
- Yi Lv, MD,PHD, Principal investigator, China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774589
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-001-1
- Acronym
- BAMCT
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03774589
- Acronym / sponsor ID
- BAMCT / XJTU1AF-CRF-2015-001-1
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Bile Duct Injury, Choledochal Cyst, Biliary Calculi
- Keywords
- bilioenteric anastomosis, magnetic compressive technique, morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University, Northwest Institute for Non-ferrous Metal Research
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
Detailed description
The bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Compressive Anastomosis | Experimental | Procedure: Magnetic Compressive AnastomosisA magnetic device will be used during bilioenteric anastomosis. |
| Traditional Manual Anastomosis | Active comparator | Procedure: Manual AnastomosisA handsewn technique will be used during bilioenteric anastomosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age between 18 to 75
- Patients' gender was not limited
- Patients who were well-diagnosed and had the indication for bilioenteric anastomosis.
- Patients whose lifetimes will be longer than 12 months.
- Patients who are willing to join this clinical trial and informed consent form voluntarily.
Key exclusion criteria (7 listed)
- Woman during pregnancy or lactation or anyone with mental disorder
- The wall of hepatic duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
- Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
- Any foreign body has been implanted in body, such as heart pacemaker.
- Surgical contraindication, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Compressive AnastomosisThe magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis. | Procedure or surgery | Magnetic Compressive Anastomosis |
| Manual AnastomosisA handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis. | Procedure or surgery | Traditional Manual Anastomosis |
Primary outcome
Bilioenteric anastomotic leakage
Time frame: 1 month post operation
To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis
4 secondary outcomes
Length of bilioenteric anastomosis time
Time frame: during operation
Time from the date of operation to expel of the magnets.
Time frame: 1 to 4 weeks postoperation
average length of postoperative hospital stay
Time frame: 3 months
Bilioenteric anastomotic stricture
Time frame: 1,3,6,12-month post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Lv, MD,PHD principal investigator
China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Compressive Anastomosis and Manual Anastomosis in people with Pancreatic Cancer and Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Lv, MD,PHD (86-29-85323900, luyi169@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilioenteric anastomotic leakage (time frame: 1 month post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.